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QA Validation Engineer

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This is a full-time, direct/perm opportunity located in Janesville, WI. This position requires relocation to WI, it is NOT REMOTE!

Immediately seeking a QA Validation Engineer to develop, review, and manage the execution of validation activities for the facility utilities, equipment and processes used in the manufacture and testing of cGMP products. Validation Engineers are recognized as a strong quality presence and technical resource.

Responsibilities:

Establish a Master Validation Plan, review and implement all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
Develop and prepare protocols for process and cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ).
Coordinate and oversee scheduled validation and qualification activities with facility and production engineers and operators, process and analytical development personnel, quality control staff, customers and external contractors and service providers.
Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis).
Be a member of the Change Management System to determine the impact of proposed changes to the validation/qualification status of equipment, processes, software, and/or facilities.
Develop and provide training and mentoring on validation concepts.
Report status and progress of validation/qualification activities or projects to the Leadership team.
Requirements

B.S. in an Engineering discipline, Radiochemistry or Life Science degree.
4-7 years quality or quality support experience in a cGMP pharmaceutical setting or 4-7 years facility, equipment, and/or cleaning validation experience in a cGMP manufacturing setting.
Sound working knowledge of processing equipment used to manufacture Raw Materials and/or APIís.
Demonstrated proficiency with various laboratory techniques/instruments such as spectroscopy (alpha/beta, gamma, UV/Vis), chromatography (IC, HPLC, TLC), trace metal analysis (AA, ICP), and wet chemistry techniques.
Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.
Ability to utilize GDP during document creation and review.
Working knowledge of current Good Manufacturing Process and/or Nuclear Regulatory Commission guidelines and standards.
Ability to apply and incorporate nuclear and pharmaceutical standards, rules and guidance. (e.g. NRC, FDA, EU, ISO, ICH, ISPE, etc.)
Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
Flexible and accountable.
Detailed oriented work standards.
Travel Requirements: up to 10%


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